FDA Enforcement Report for March 19, 2014 Includes Veterinary Soft Chews from Sogeval Laboratories Inc

Veterinary	***Joint Support for Dogs***SYNOVIAL-FLEX SOFT CHEWS***TRP*Advanced Soft Chew Technology***Combining Glucosamine HCl, MSM, Creatine Monohydrate, Perna Canaliculus, Omega-3 Fatty Acids and Antioxidants in a Palatable Liver Flavored Chew***SOGEVAL***Shared solutions***Net Content: Contains 120 soft chews***	Model # FNGL9002120, Lot # 52070-1 exp 12/2015.	Class III	Consumer complaint of the smell of their Synovial Flex Soft Chews associated with Joint Max Double Strength soft chews that were inadvertently mislabeled as Synovial Flex Soft Chews.	Sogeval Laboratories Inc
Devices	plastic tissue. The IHC PR Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitation measurement of PR (Progesterone Receptor) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer. Note: The IHC ER and PR Image Analysis applications are an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of estrogen and progesterone receptor proteins. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the ER and PR reagent/kit used to assure the validity of the IHC ER and PR Image Analysis application assisted scores. IHC PR Breast Tissue Manual Read of Digital Slides: The ScanScope® System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The ScanScope® system is intended for use as an aid to the pathologist in the detection and quantitative measurement of PR (Progesterone Receptor) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for PR on a computer monitor. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.	23elHCKIT2500, 23elHCKIT5000, 23elHCKIT500.	Class II	In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional information to clarify that the use of Digital IHC Breast/ER/Dako Image Analysis, Digital IHC Breast/HER2 Digital Read, Digital IHC Breast/HER2/Dako Image Analysis, Digital IHC Breast/PR Digital Read and Digital IHC Breast/PR/Dako Image Analysis with the RUO products identified in that earlier notification is also for Research Use Only and not for use in diagnostic procedures. As a result, we are including with this notice updated manuals for the image analysis algorthithms listed above so that the intended use in the hardware and software manuals is consistent.	Leica Biosystems Imaging, Inc.
Devices	VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum.	0020, 0030, 0040, 0050, 0060, 0070, 0081, 0090, 0100, 0110	Class III	Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate negatively biased results. As a result, users must immediately discontinue using all current lots of VITROS 25-OH Vitamin D Total Calibrators and Reagent Packs.	Ortho-Clinical Diagnostics
Devices	Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.	P/N 1462-333, Size M, Lot # M130010	Class II	Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.	Carl Zeiss Meditec AG
Devices	CELLTRACKS ANALYZER II® (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS® software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS® software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II® is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS® AUTOPREP® System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.	First: K050145, cleared 15 March 2005 Latest: K130794, cleared 20 June 2013 9555 Serial numbers: CT1106005 CT1104002 CT1108006 CT1111009 CT1201001 CT1203004 CT1205011 CT1205012 CT1206013 CT1210022 CT1210024	Class II	Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II®.	Veridex, LLC
Biologics	Red Blood Cells Leukocytes Reduced	W333613106336	Class II	Blood product, which was labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count for leukoreduced products, was distributed.	Mississippi Valley Reg Bld Ctr
Biologics	Red Blood Cells Leukocytes Reduced	W069113134332	Class II	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.	Mississippi Blood Services Inc.
Biologics	Recovered Plasma	W069113134332	Class III	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.	Mississippi Blood Services Inc.
Devices	Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician	MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587	Class II	When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.	Philips Medical Systems, Inc.
Devices	bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.	Serial number range: AS 180-00001 to AS 180-00476	Class II	The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result.	Biomerieux Inc
Devices	GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.	Serial Numbers for all devices: 22, 343, 1002, 1003, 1006, 1007, 1008, 1010, 1012, 1013, 1016, 1018, 1019, 1021, 1025, 1026, 1027, 1034, 1035, 1038, 1039, 1042, 1043, 1046, 1056, 1058, 1060, 1061, 1065, 1066, 1069, 1072, 1073, 1074, 1075, 1076, 1078, 1080, 1081, 1085, 1086, 1091, 1095, 1099, 1100, 1101, 1101, 1102, 1105, 1106, 1107, 1110, 1111, 1112, 1116, 1118, 1119, 1126, 1132, 1141, 1144, 1145, 1149, 1153, 1155, 1289, 1372, 1505, 1538, 1617, 1629, 1649, 1666, 1693, 1696, 1697, 1704, 1729, 1730, 1756, 1804, 1814, 1831, 1835, 1890, 1998, 1999, 3003, 5004, 5007, 8007, 10023, 10028, 10032, 10040, 10041, 10057, 10103, 10115, 10121, 10124, 10129, 10130, 10133, 10138, 10139, 10143, 10146, 10146, 10150, 10156, 10158, 10164, 10165, 10166, 10167, 10168, 10169, 10171, 10172, 10173, 10175, 10176, 10177, 10178, 10179, 10180, 10180, 10182, 10185, 10187, 10188, 10189, 10190, 10191, 10193, 10194, 10195, 10197, 10199, 10204, 10206, 10207, 10209, 10210, 10211, 10212, 10216, 10217, 10218, 10222, 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17942, 17943, 17944, 17947, 17948, 17949, 17950, 17951, 17952, 17953, 17954, 17955, 17956, 17957, 17958, 17959, 17960, 17961, 17962, 17964, 17965, 17966, 17967, 17968, 17969, 17970, 17971, 17972, 17973, 17974, 17975, 17976, 17977, 17978, 17979, 17980, 17981, 17982, 17983, 17984, 17985, 17986, 17987, 17988, 17991, 17992, 17993, 17994, 17995, 17996, 17997, 17998, 17999, 18000, 18001, 18002, 18003, 18004, 18005, 18006, 18007, 18008, 18009, 18010, 18011, 18012, 18014, 18015, 18016, 18017, 18018, 18019, 18020, 18021, 18024, 18025, 18026, 18027, 18028, 18029, 18030, 18031, 18032, 18033, 18034, 18035, 18036, 18037, 18038, 18039, 18040, 18041, 18042, 18043, 18044, 18045, 18046, 18047, 18048, 18049, 18051, 18052, 18054, 18055, 18056, 18057, 18058, 18059, 18060, 18062, 18063, 18064, 18065, 18066, 18067, 18068, 18069, 18070, 18071, 18072, 18073, 18074, 18075, 18076, 18078, 18080, 18081, 18082, 18083, 18084, 18085, 18086, 18087, 18088, 18089, 18090, 18091, 18092, 18093, 18094, 18095, 18096, 18097, 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18250, 18251, 18252, 18253, 18254, 18255, 18256, 18257, 18258, 18259, 18260, 18261, 18262, 18263, 18264, 18265, 18266, 18267, 18268, 18269, 18270, 18271, 18272, 18273, 18274, 18275, 18278, 18279, 18280, 18281, 18282, 18283, 18284, 18285, 18286, 18287, 18288, 18289, 18290, 18291, 18292, 18293, 18294, 18295, 18296, 18297, 18298, 18299, 18300, 18301, 18302, 18303, 18304, 18305, 18306, 18307, 18308, 18309, 18310, 18311, 18313, 18314, 18315, 18316, 18317, 18318, 18319, 18320, 18321, 18322, 18323, 18324, 18325, 18326, 18327, 18328, 18329, 18330, 18331, 18332, 18333, 18334, 18335, 18336, 18337, 18338, 18339, 18340, 18341, 18342, 18343, 18344, 18345, 18346, 18347, 18348, 18349, 18350, 18351, 18352, 18353, 18354, 18355, 18356, 18357, 18358, 18359, 18360, 18361, 18363, 18364, 18365, 18366, 18367, 18368, 18369, 18370, 18371, 18372, 18373, 18374, 18375, 18376, 18377, 18378, 18379, 18380, 18381, 18382, 18383, 18384, 18385, 18386, 18387, 18388, 18389, 18390, 18391, 18392, 18393, 18394, 18395, 18396, 18397, 18398, 18399, 18400, 18401, 18403, 18404, 18405, 18406, 18407, 18408, 18409, 18410, 18411, 18412, 18413, 18415, 18416, 18417, 18418, 18419, 18420, 18421, 18422, 18423, 18424, 18425, 18426, 18427, 18429, 18430, 18431, 18432, 18433, 18434, 18435, 18436, 18437, 18438, 18439, 18440, 18441, 18442, 18443, 18444, 18445, 18446, 18448, 18449, 18450, 18451, 18452, 18453, 18454, 18455, 18456, 18458, 18459, 18460, 18461, 18462, 18463, 18464, 18465, 18466, 18467, 18468, 18469, 18470, 18471, 18472, 18473, 18474, 18475, 18476, 18477, 18478, 18479, 18480, 18481, 18482, 18483, 18484, 18485, 18486, 18487, 18488, 18489, 18490, 18491, 18492, 18493, 18494, 18495, 18496, 18498, 18499, 18500, 18501, 18502, 18503, 18504, 18505, 18506, 18507, 18508, 18509, 18510, 18511, 18512, 18513, 18514, 18515, 18516, 18517, 18518, 18519, 18520, 18521, 18522, 18523, 18524, 18525, 18526, 18527, 18528, 18529, 18530, 18531, 18532, 18533, 18534, 18535, 18536, 18537, 18538, 18539, 18540, 18541, 18542, 18543, 18544, 18545, 18546, 18547, 18548, 18550, 18551, 18552, 18553, 18554, 18555, 18556, 18557, 18560, 18561, 18562, 18563, 18564, 18565, 18566, 18567, 18568, 18569, 18570, 18571, 18572, 18573, 18574, 18575, 18576, 18577, 18578, 18579, 18580, 18581, 61061, 3874990, 36478041, 40772394, 00000000005BH9, 00000000009BH1, 00000000010-01, 00000000010-04, 00000000010-05, 00000000010-15, 00000000010-30, 00000000010-31, 00000000010-37, 00000000010-44, 00000000010-45, 00000000010-50, 00000000010-54, 00000000010-55, 00000000010-59, 00000000010-63, 00000000010-64, 00000000010-67, 00000000010-82, 00000000011-34, 00000000011-57, 00000000011-85, 00000000012-15, 00000000012-20, 00000000012-22, 00000000012BH5, 00000000015-22, 00000000015BH8, 00000000016-17, 00000000016-71, 00000000016-73, 00000000016-86, 00000000016-91, 00000000017-10, 00000000017-15, 00000000017-20, 00000000017-22, 00000000017-23, 00000000017-27, 00000000017-31, 00000000017-36, 00000000017-64, 00000000018-08, 00000000018-22, 00000000018-23, 00000000018-24, 00000000018-39, 00000000018-40, 00000000018-42, 00000000018BH2, 00000000019-34, 00000000021BH6, 00000000026BH5, 00000000027BH3, 00000000030-04, 00000000030-11, 00000000030-14, 00000000030-15, 00000000030-16, 00000000030BH7, 00000000031-11, 00000000032-10, 00000000032-13, 00000000033BH1, 00000000034-11, 00000000036BH4, 00000000041BH4, 00000000043-82, 00000000044-10, 00000000044BH8, 00000000045BH5, 00000000050-08, 00000000050BH5, 00000000053BH9, 00000000054-04, 00000000056BH2, 00000000059BH6, 00000000062BH0, 00000000065BH3, 00000000068BH7, 00000000069BH5, 00000000077BH8, 00000000078BH6, 00000000086BH9, 00000000091BH9, 0000000010-134, 0000000010-191, 0000000010-203, 00000000109BH9, 00000004-4-604, 000000099-4-04, 00000011278NU9, 000000163-1758, 00000054895HL8, 00000054915HL4, 00000055050HL9, 00000056555HL6, 00000061940HL3, 00000087649BT0, 00000163-15-28, 000003100-1716, 000003100-1719, 000003100-1740, 000003100-1743, 000003100-1744, 000003100-1760, 000003100-1763, 000003100-1829, 000003100-1838, 000003100-1840, 000003101-1502, 000003651-4185, 000003681-1803, 000003818-1210, 000003818-1224, 000003818-4187, 000008125-1630, 00000I92S08001, 00000ICPO50612, 00003618-12-26, 00003652-41-95, 00003817-11-12, 00003817-11-69, 00003818-11-41, 00003818-11-47, 00003818-11-82, 00003818-12-19, 00003818-32-02, 00008125-16-25, 00008125-16-70, 00008125-16-88, 00008125-16-89, 00008125-18-09, 00008125-18-10, 00008125-18-16, 00008125-18-18, 0000D4360X4372, 0003811-81-231, DUMFMI40849005, DUMFMI40849009, DUMFMI40849010, DUMFMI40849011, DUMFMI40849012, DUMFMI40849013, DUMFMI40849014, DUMFMI40849015, DUMFMI40849016, DUMFMI40849017, DUMFMI40849018, DUMFMI40849019, DUMFMI40849020, DUMFMI40849023, DUMFMI40849026, UNKASM00109200, UNKASM00109201, UNKASM00109204, UNKELS00000372.	Class II	Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. No injuries have been reported.	GE Healthcare, LLC
Devices	GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.	all serial numbers are listed in Product 1	Class II	Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. No injuries have been reported.	GE Healthcare, LLC
Devices	Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.	all serial numbers are listed in Product 1.	Class II	Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. No injuries have been reported.	GE Healthcare, LLC
Devices	RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.	no lot numbers: RetCam 3 (RC3, Part number 21-100500; Serial numbers: RC3125 RC6003 RC6004 RC6005 RC6006 RC6007 RC6008 RC6009 RC6010 RC6011 RC6012 RC6013 RC6014 RC6015 RC6016 RC6017 RC6018 RC6019 RC6020 RC6021 RC6022 RC6023 RC6024 RC6025 RC6026 RC6027 RC6028 RC6029 RC6030 RC6031 RC6033 RC6034 RC6035 RC6036 RC6037 RC6038 RC6039 RC6040 RC6041 RC6042 RC6043 RC6044 RC6045 RC6046 RC6047 RC6048 RC6049 RC6050 RC6051 RC6052 RC6053 RC6054 RC6055 RC6056 RC6057 RC6058 RC6059 RC6060 RC6061 RC6062 RC6063 RC6064 RC6065 RC6066 RC6067 RC6068 RC6069 RC6070 RC6071 RC6072 RC6073 RC6074 RC6075 RC6076 RC6077 RC6078 RC6079 RC6080 RC6081 RC6082 RC6083 RC6084 RC6085 RC6086 RC6087 RC6088 RC6089 RC6090 RC6091 RC6092 RC6093 RC6094 RC6095 RC6096 RC6097 RC6098 RC6099 RC6100 RC6101 RC6102 RC6103 RC6104 RC6105 RC6106 RC6107 RC6108 RC6109 RC6110 RC6111 RC6112 RC6113 RC6300 RC6301 RC6302 RC6303 RC6304 RC6305 RC6306 RC6307 RC6308 RC6309 RC6310 RC6311 RC6312 RC6313 RC6314 RC6315 RC6316 RC6317 RC6318 RC6319 RC6320 RC6321 RC6322 RC6323 RC6324 RC6325 RC6326 RC6327 RC6328 RC6329 RC6330 RC6331 RC6332 RC6333 RC6334 RC6335 RC6336 RC6337 RC6338 RC6339 RC6340 RC6341 RC6342 RC6343 RC6344 RC6345 RC6346 RC6347 RC6348 RC6349 RC6350 RC6351 RC6352 RC6353 RC6354 RC6355 RC6356 RC6357 RC6358 RC6359 RC6360 RC6361 RC6362 RC6363 RC6364 RC6365 RC6366 RC6367 RC6368 RC6369 RC6370 RC6371 RC6372 RC6373 RC6374 RC6375 RC6376 RC6377 RC6378 RC6379 RC6380 RC6381 RC6382 RC6383 RC6384 RC6385 RC6386 RC6387 RC6388 RC6389 RC6390 RC6391 RC6392 RC6393 RC6394 RC6395 RC6396 RC6397 RC6398 RC6399 RC6400 RC6401 RC6402 RC6403 RC6404 RC6405 RC6406 RC6407 RC6408 RC6410 RC6411 RC6412 RC6413 RC6414 RC6415 RC6416 RC6417 RC6418 RC6419 RC6420 RC6421 RC6422 RC6423 RC6424 RC6425 RC6426 RC6427 RC6428 RC6429 RC6430 RC6431 RC6432 RC6433 RC6434 RC6435 RC6436 RC6437 RC6438 RC6439 RC6440 RC6441 RC6442 RC6443 RC6444 RC6445 RC6446 RC6447 RC6448 RC6449 RC6450 RC6451 RC6452 RC6453 RC6454 RC6455 RC6456 RC6457 RC6458 RC6459 RC6460 RC6461 RC6462 RC6463 RC6464 RC6466 RC6467 RC6469 RC6470 RC6471 RC6472 RC6473 RC6474 RC6475 RC6476 RC6477 RC6480 RC6486 RetCam Portable (RTP), Part number 23-00100; serial numbers: RP6003 RP6004 RP6005 RP6006 RP6007 RP6008 RP6009 RP6010 RP6301 RP6302 RP6303 RP6304 RP6305 RP6306 RP6307 RP6307 RP6308 RP6309 RP6310 RP6311 RP6312 RP6313 RP6314 RetCam Shuttle (RCS), Part number 20-000300; Serial number: RS3074 RS6001 RS6002 RS6003 RS6004 RS6005 RS6006 RS6007 RS6008 RS6009 RS6010 RS6011 RS6012 RS6013 RS6014 RS6015 RS6016 RS6017 RS6018 RS6019 RS6020 RS6021 RS6022 RS6023 RS6024 RS6025 RS6026 RS6027 RS6028 RS6029 RS6030 RS6031 RS6032 RS6033 RS6034 RS6035 RS6036 RS6037 RS6038 RS6039 RS6040 RS6041 RS6042 RS6043 RS6044 RS6045 RS6046 RS6047 RS6048 RS6049 RS6050 RS6051 RS6052 RS6053 RS6054 RS6055 RS6056 RS6057 RS6058 RS6059 RS6060 RS6061 RS6062 RS6063 RS6064 RS6065 RS6066 RS6067 RS6068 RS6069 RS6070 RS6071 RS6301 RS6302 RS6303 RS6304 RS6305 RS6306 RS6307 RS6308 RS6309 RS6310 RS6311 RS6312 RS6313 RS6314 RS6315 RS6316 RS6317 RS6318 RS6319 RS6320 RS6321 RS6322 RS6323 RS6324 RS6325 RS6326 RS6327 RS6328 RS6329 RS6330 RS6331 RS6332 RS6333 RS6334 RS6335 RS6336 RS6337 RS6338 RS6339 RS6340 RS6341 RS6342 RS6343 RS6344 RS6345 RS6346 RS6347 RS6348 RS6349 RS6350 RS6352 RS6353 RS6354 RS6355 RS6356 RS6357 RS6358 RS6359 RS6360 RS6361 RS6362 RS6363 RS6364 RS6365 RS6366 RS6367 RS6368 RS6369 RS6370 RS6371 RS6372 RS6373 RS6374 RS6375 RS6376 RS6377 RS6378 RS6379 RS6380 RS6381 RS6382 RS6383 RS6384 RS6385 RS6386 RS6387 RS6388 RS6389 RS6390 RS6391 RS6392 RS6393 RS6394 RS6395.	Class II	Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.	Clarity Medical Systems Inc
Devices	Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491	Serial numbers within the range: US00100204 to US00570921	Class II	MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing	Philips Medical Systems, Inc.
Food	Valued Naturals Natural Coconut Net wt. 8oz (216.80g) Imported by Philippines International Foodsource LLC 52 Richboynton Rd, Dover, NJ 07801 Packaged in 8 oz bag 12 per case.	UPC 7-90429-22603-6 Retail Lots - 62289, 62752, 63046, 63374, 63541, 63614, 63800 UPC 7-90429-22603-6 12x6x6 (5# boxes) - 63059	Class III	NYSDAM Laboratory Analysis Reports has determined that Valued Naturals Natural Coconut contains 28.1 ppm sulfites.	International Foodsource, LLC
Devices	Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)	ALL LOT #s 2013010311 and lower	Class II	Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm.	Smith & Nephew Inc.
Devices	Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)	ALL LOT #'s: 2013011828 and lower- Small, 2013010125 and lower- Medium, and 2013011692 and lower - Large	Class II	Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm.	Smith & Nephew Inc.
Devices	Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)	ALL LOT #: 2013011830 and lower	Class II	Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm.	Smith & Nephew Inc.
Devices	Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)	ALL LOT #'s: 2013020417 and lower - Small, 2013020209 and lower- Medium, 2013020382 and lower - Large, and 2013020501 and lower- X-Large	Class II	Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm.	Smith & Nephew Inc.
Devices	Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)	ALL LOT #s 2013020740 and lower	Class II	Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm.	Smith & Nephew Inc.
Devices	Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)	ALL LOT #'s 2013010287 and lower	Class II	Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm.	Smith & Nephew Inc.
Food	Roasting Cinnamon Butternut Squash Net Wt. 2 lbs (907 g) Foam Tray with 3 per case. Keep Refrigerated Distributed by Renaissance Food Group LLC UPC 825786790333	Best by Dates of 1/5/14; 1/7/14; 1/8/14	Class II	Roasting cinnamon butternut squash is mislabeled.	F & S Produce Co., Inc.
Food	Colon Rebuild I (90 capsules), 2boxes x 240 bottles, 1box x 200 bottles.	Colon Rebuild I, Lot 1471	Class II	Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.	Global Vitality, Inc. dba Enzyme Process International
Food	Fat Sugar (bulk), 3 boxes x 12 kg, 1 box x 8.76 kg.	Lot 1845	Class II	Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.	Global Vitality, Inc. dba Enzyme Process International
Food	Adrenal Support (bulk), 4 boxes x 12 kg, 1 box x 11.48 kg.	Lot 2037	Class II	Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.	Global Vitality, Inc. dba Enzyme Process International
Food	Energy Clarity (bulk), 6 boxes x 15 kg, 1 box x 10.55 kg.	Lot 1843	Class II	Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.	Global Vitality, Inc. dba Enzyme Process International
Food	Multi Vitamin (bulk), 6 boxes x 12 kg, 1 box x 5.5kg.	Lot 1671	Class II	Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.	Global Vitality, Inc. dba Enzyme Process International
Food	Total Digestion, Lot 1635, 4 boxes x 9.92 kg. Lot 1841, 4 boxes x 12 kg, 1 box x 11.24 kg. Lot 2017, 3 boxes x 10 kg, 1 box x 9.32 kg.	Lot 1635, 1841, and 2017	Class II	Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.	Global Vitality, Inc. dba Enzyme Process International
Food	Pain Power, 100 vegetarian capsules, 55 boxes x 72 bottles, 1 box x 7 bottles.	Lot 1533	Class II	Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.	Global Vitality, Inc. dba Enzyme Process International
Food	Super Digestayme, 200 count, 2 boxes x 72 bottles, 1 box x 55 bottles. 300 count, 4 boxes x 72 bottles, 1 box x 12 bottles.	Lot 1585	Class II	Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.	Global Vitality, Inc. dba Enzyme Process International
Food	Colon Rebuild II, 210 capsules, 6 boxes x 72 bottles, 1 box x 70 bottles.	Lot 1579	Class II	Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol.	Global Vitality, Inc. dba Enzyme Process International
Devices	Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.	p/n 0998-00-0708-01; 0998-UC-0708-01 and 0020-00-0205-XXX	Class II	Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindray¿s V-Series Monitor. Additionally, event indicators lag behind the Panorama system time clock when the Panorama Central Station is in use with a Panorama Telepack.	Mindray DS USA, Inc. dba Mindray North America
Food	Classic Sysco Custom Ready to Use Cherry Pie Filling; with other Natural Flavors #10 can - Net wt 7 lbs (3.18kg) UPC 1 00 74865 38257 8 Manufactured for Sysco by Lyons Magnus, Fresno, CA	Item 1846; Cherry Pie code 8004 SUPC 6346134	Class II	Precautionary withdrawal after inspection found metal on metal contact on an augur used in production. No metal has been discovered in any of the product.	Lyons Magnus
Food	Classic Sysco Custom Ready to Use Blueberry Pie Filling; Artificial Flavor #10 can - Net wt 7 lbs 1 oz (2kg) UPC 1 00 74865 38258 5 Manufactured for Sysco by Lyons Magnus, Fresno, CA	Item 1847; Cherry Pie code 9204 SUPC 6346167	Class II	Precautionary withdrawal after inspection found metal on metal contact on an augur used in production. No metal has been discovered in any of the product.	Lyons Magnus
Food	MORRISON'S BROWN GRAVY MIX, NET WT 13 OZ (369 g) mislabeled as MORRISON'S PANCAKE MIX, NET WT 5 LB (2.27 kg)	Lot number 3357	Class II	brown gravy mix product mislabeled as pancake mix, resulting in undeclared soy (as hydrolyzed vegetable protein)	C. H. Guenther & Sons, Inc.
Devices	VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow IIb/IIIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow Ilb/Illa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.	Lot/Serial No. WC0182B, WC0182C, WC0182A, WC0182D, WC0182E, WC0182F, WC0182G, WC0180C, WC0180E, WC0180F, WC0181A, WC0181C, WC0181D, WC0181F, WC0180A, WC0180B, WC0180D, WC0181B, WC0181E, WC0181G, WC0181H, WC0181J, WC0181K.	Class II	Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An erroneous low PAU result may cause a low percent inhibition calculation or low baseline PAU.	Accumetrics Inc
Food	Jalapeno Ground 40, Elite Spice Code #JP9520, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***	Lot 1-227954	Class I	Bulk spice for futher manufacturing may be contaminated with Salmonella.	Elite Spice Inc.
Food	Jalapeno Nut Seasoning, Elite Code # 35076A2, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***	Lot 1-230880	Class I	Bulk spice for futher manufacturing may be contaminated with Salmonella.	Elite Spice Inc.
Food	Chipotle Nut Seasoning, Elite Code # 38113A2, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***	Lot 1-230879	Class I	Bulk spice for futher manufacturing may be contaminated with Salmonella.	Elite Spice Inc.
Food	Ole Hot Chorizo Seasoning, Elite Spice # 32581A9, 32 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***	Lot 1-230758	Class I	Bulk spice for futher manufacturing may be contaminated with Salmonella.	Elite Spice Inc.
Food	Mexican Style Mild Chorizo, Elite Spice # 32582A9, 24 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***	Lot 1-230647	Class I	Bulk spice for futher manufacturing may be contaminated with Salmonella.	Elite Spice Inc.
Food	Jalapeno Burger Seasoning, Elite Spice # 32680B2, 50 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794***	Lots 1-230813 and 1-230814	Class I	Bulk spice for futher manufacturing may be contaminated with Salmonella.	Elite Spice Inc.
Devices	MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.	Order Number Model Number and Description Lot number 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 15674-05 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 15929-05 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 16115-06 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 16346-06 70105.0967 BO-T 1260 Adult Cardioplegia Pack 15760-07 70105.0975 BO-TOP 26300 Custom Pack 15796-13 70105.1736 BEQ-TOP 4903 Open Heart Pack 15921-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16073-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16153-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16321-07 70105.1861 BO-TOP 14601 Open Heart Tubing Pack 15880-02 70105.2463 BO-T 25102 Custom Pack 15755-07 70105.2463 BO-T 25102 Custom Pack 15889-07 70105.2463 BO-T 25102 Custom Pack 16046-07 70105.2463 BO-T 25102 Custom Pack 16155-07 70105.2463 BO-T 25102 Custom Pack 16267-07 70105.2650 BO-TOP 23102 Scott &White OR CPB Pack 15818-10 70105.2659 BO-TOP 4903 Adult Open Heart Pack 15780-03 70105.2659 BO-TOP 4903 Adult Open Heart Pack 16047-03 70105.3832 BO-TOP 32400 Adult CPB Pack 15814-06 70105.3832 BO-TOP 32400 Adult CPB Pack 16063-06 70105.3832 BO-TOP 32400 Adult CPB Pack 16449-06 70105.5015 BO-TOP 36500 Cardiac Surgery 15658-13 70105.5015 BO-TOP 36500 Cardiac Surgery 15772-13 70105.5015 BO-TOP 36500 Cardiac Surgery 15883-16 70105.5015 BO-TOP 36500 Cardiac Surgery 16078-16 70105.5015 BO-TOP 36500 Cardiac Surgery 16250-16 70105.5015 BO-TOP 36500 Cardiac Surgery 16410-17 70105.6041 BEQ-T 4906 Pediatric CPB Pack w/o VKMO 15819-02 70105.6238 BO-TOP 38800 Open Heart Pack 15635-05 70105.6238 BO-TOP 38800 Open Heart Pack 16013-05 70105.6867 BO-TOP 4112 1/4x3/16 Neonatal Pack 16039-09 70105.6867 BO-TOP 4112 1/4x3/16 Neonatal Pack 16238-10 70105.6869 BO-TOP 4113 Pediatric 1/4x3/8 15574-03 70106.2237 T 24260 St Louis Children´s Cardioplegia 15659-05 70106.2237 T 24260 St Louis Children´s Cardioplegia 15967-05 70106.2707 BEQ-TOP 40000 Open Heart Pack 15892-05 70106.2707 BEQ-TOP 40000 Open Heart Pack 16122-07 70106.2707 BEQ-TOP 40000 Open Heart Pack 16224-07 70106.3071 BEQ-TOP 30901 Custom CPB Pack 15783-05 70106.3071 BEQ-TOP 30901 Custom CPB Pack 15923-05 70106.3071 BEQ-TOP 30901 Custom CPB Pack 15998-05 70106.3071 BEQ-TOP 30901 Custom CPB Pack 16239-05 70106.3071 BEQ-TOP 30901 Custom CPB Pack 16387-05 70106.3364 BO-T 41760 Robert Packer Plegiox Set 15845-03 70106.3364 BO-T 41760 Robert Packer Plegiox Set 15976-03 70106.3364 BO-T 41760 Robert Packer Plegiox Set 16120-03 70106.3623 BO-T 31261 Plegiox Pack 15800-04 70106.3623 BO-T 31261 Plegiox Pack 15924-04 70106.3623 BO-T 31261 Plegiox Pack 16112-04 70106.3623 BO-T 31261 Plegiox Pack 16145-04 70106.3623 BO-T 31261 Plegiox Pack 16184-04 70106.4327 BO-TOP 48400 OR Pack 16169-01 70106.4327 BO-TOP 48400 OR Pack 16310-01 70106.5315 BEQ-T 16403 Liver TX 16114-06 70106.6206 BEQ-TOP 38307 Adult Pack 15931-03 70106.6398 BEQ-TOP 48000 Open Heart WITH Oxygenator 15932-02 70106.6400 BEQ-TOP 48001 Open Heart WITH OXY 15933-02 70106.6461 BEQ-TOP 38310 Small Adult Pack 15934-02 70106.6664 BEQ-T 4903 Open Heart Pack with NO VKMO 16040-01 70106.6712 BO-T 14601 Open Heart WITHOUT VKMO 16067-01 70106.6713 BEQ-T 40000 Open Heart WITHOUT VKMO 16056-01 70106.6738 BO-T 26300 Transitional Cardiac Surgery Pk 16146-01 70106.6914 BEQ-T 4961 Cardioplegia Pack 4:1 16240-01	Class II	The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardioplegia Heat Exchanger (PLEGIOX) is used in conjunction with a heater/cooler unit.	Maquet Cardiovascular Us Sales, Llc
Devices	Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.	serial numbers: 1289064, 1289069, 1289159, 1289259, 1289387, 1289650, 1289747, 1289826, 1289949, 1290088, 1290151, 1290333, 1290367, 1290480, 1290489, 1290845, 1290988, 1291042, 1291120, 1291233, 1291373, 1291378, 1291634, 1291777, 1291828, 1291933, 1292031, 1292114, 1292185, 1292185, 1292192, 1292391, 1292546, 1292597, 1292670, 1292674, 1292899, 1292960, 1293010, 1293039, 1293185, 1293190, 1293311, 1293379, 1293414, 1293687, 1293724, 1293771, 1293777, 1293953, 1293957, 1294093, 1294103, 1294171, 1294307, 1294362, 1294433, 1294516, 1294589, 1294727, 1294864, 1294999, 1295113, 1295137, 1295160, 1295186, 1295274, 1295391, 1295514, 1295622, 1295813, 1295871, 1296237, 1296241, 1296246, 1296484, 1296491, 1296582, 1296621, 1296650, 1296695, 1296806, 1297041, 1297046, 1297118, 1297231, 1297234, 1297372, 1297375, 1297394, 1297453, 1297484, 1297610, 1297655, 1297939, 1297943, 1298037, 1298210, 1298266, 1298270, 1298377, 1298407, 1298450, 1298457, 1298575, 1298619, 1298624, 1298704, 1298734, 1298797, 1298820, 1298879, 1298913, 1298952, 1298953, 1299037, 1299120, 1299144, 1299170, 1299241, 1299262, 1299285, 1299331, 1299393, 1299473, 1299512, 1299599, 1299655, 1299656, 1299732.	Class II	There exists a potential situation with the crimp connection at the pump head assembly. The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components. If this occurs, the pump head assembly may experience melting of the plastic components and potentially create smoke/fire and shut down of the unit.	Mar Cor Purification
Drugs	Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50	Lot # 1826E131, Exp 04/2015	Class II	Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.	Actavis Elizabeth LLC
Devices	Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,± 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.	Catalog number 0007Cm; lot number 1211158R; Expiration May 14, 2014.	Class II	Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products.	Lin-Zhi International Inc
Devices	Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor- 9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor- 9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,± 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.	Catalog number 0008c; lot number 1211160R; Expiration May 14, 2014.	Class II	Product catalog # s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products.	Lin-Zhi International Inc
Devices	Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.	Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A	Class II	HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System.	Horiba Instruments, Inc dba Horiba Medical
Food	STONEWALL KITCHEN brand Chocolate Coconut Cupcake Mix, Net Wt. 22.5 oz. (637.9 g), UPC 7 11381 31535 4 -- DISTRIBUTED BY STONEWALL KITCHEN, STONEWALL LANE, YORK, ME 03909	Enjoy By Dates: 17 APR 2014 1, 16 AUG 2014 1, 03 SEPT 2014 1, 21 OCT 2014 1, 27 NOV 2014 1, 20 JAN 2015 1, 7 FEB 2015 1	Class II	Labeling error. The cupcake mix is made with coconut milk powder which contains the sub-ingredients coconut milk and sodium caseinate (milk). These are listed in the ingredient statement. The "Contains" allergen statement lists Soy, Tree Nuts (coconut), and Wheat, but Milk is not listed.	Raymond-Hadley Corp.
Devices	PENTARAY NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128204, D128205. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.	Lot Numbers: 15791519L 15803349L 15825343L 15845012L 15852437L 15859153L 15869785L 15793496L 15803350L 15825344L 15845013L 15852438L 15859154L 15869786L 15793497L 15803351L 15825345L 15845014L 15854132L 15859155L 15869787L 15793499L 15803352L 15825346L 15845015L 15854136L 15859156L 15869788L 15793500L 15803353L 15825347L 15845016L 15854141L 15859157L 15869789L 15793502L 15803354L 15825348L 15845017L 15854145L 15859158L 15869790L 15795833L 15803355L 15825863L 15845018L 15854147L 15859159L 15869791L 15795836L 15805357L 15825864L 15847688L 15854150L 15859160L 15872341L 15795838L 15805358L 15830258L 15847689L 15854157L 15859161L 15872342L 15795839L 15805359L 15830259L 15847690L 15854158L 15859318L 15872343L 15795843L 15805360L 15830260L 15847691L 15854161L 15859853L 15872344L 15795844L 15805361L 15830261L 15847692L 15854162L 15860904L 15872346L 15795846L 15805362L 15830262L 15847693L 15854936L 15862710L 15872347L 15795847L 15805363L 15830263L 15847694L 15854938L 15862711L 15872348L 15798652L 15805364L 15830264L 15847695L 15856101L 15862712L 15872349L 15798653L 15805365L 15830265L 15847696L 15856102L 15862714L 15872350L 15798655L 15805366L 15830266L 15847697L 15856103L 15862715L 15872351L 15798657L 15808932L 15830267L 15850674L 15856104L 15864760L 15880079L 15798659L 15808933L 15835408L 15850675L 15856105L 15864762L 15880082L 15798660L 15808934L 15835409L 15850676L 15856106L 15864763L 15881092L 15798661L 15808935L 15835410L 15850677L 15856107L 15864765L 15881093L 15798663L 15808936L 15835411L 15850690L 15856108L 15864766L 15881436L 15798664L 15808937L 15835412L 15850692L 15856109L 15864767L 15881437L 15801121L 15808938L 15835413L 15850693L 15856110L 15864768L 15881818L 15801122L 15808939L 15835414L 15850695L 15857409L 15864769L 15881819L 15801123L 15808940L 15835415L 15850696L 15857410L 15864770L 15882156L 15801124L 15808941L 15835416L 15850708L 15857411L 15864771L 15885446L 15801125L 15811171L 15835417L 15852429L 15857412L 15868804L 15885447L 15801126L 15811173L 15837216L 15852430L 15857413L 15868805L 15885819L 15801127L 15815349L 15837217L 15852431L 15857414L 15868806L 15885821L 15801128L 15815350L 15837218L 15852432L 15857415L 15868807L 15886211L 15801129L 15819831L 15839702L 15852433L 15857416L 15868808L 15886212L 15801130L 15825339L 15839707L 15852434L 15857417L 15869782L 15886466L 15803346L 15825340L 15845009L 15852435L 15857418L 15869783L 15886467L 15803347L 15825341L 15845010L 15852436L 15859152L 15869784L 15886869L 15803348L 15825342L 15845011L 15790718L 15819530L 15833155L 15839406L 15851972L 15862042L 15869295L 15790720L 15819531L 15833156L 15839407L 15851973L 15862045L 15869296L 15790722L 15825875L 15833157L 15839408L 15851974L 15862048L 15870161L 15790726L 15825877L 15833158L 15839409L 15855136L 15862050L 15870162L 15794517L 15825879L 15833159L 15839410L 15855340L 15862344L 15870491L 15794521L 15825880L 15833160L 15842777L 15855341L 15865517L 15870492L 15794522L 15825881L 15833161L 15843373L 15855343L 15865518L 15870693L 15794523L 15825882L 15833162L 15843374L 15855344L 15865519L 15870713L 15794524L 15825887L 15833163L 15843375L 15855345L 15865520L 15870714L 15794525L 15825889L 15833164L 15843376L 15855346L 15865521L 15870715L 15794526L 15825891L 15835561L 15843377L 15855347L 15865522L 15870716L 15796588L 15825893L 15835562L 15844332L 15855348L 15866141L 15870717L 15799737L 15828085L 15835564L 15844333L 15855349L 15866142L 15870718L 15799738L 15828086L 15835566L 15844334L 15855350L 15866143L 15870719L 15799739L 15828087L 15835567L 15844335L 15855727L 15866144L 15870720L 15799740L 15828088L 15835568L 15844338L 15860420L 15866145L 15870721L 15799741L 15828089L 15835569L 15844340L 15860429L 15866146L 15870722L 15799742L 15828090L 15835570L 15844344L 15860434L 15866147L 15874144L 15799743L 15831078L 15835571L 15844347L 15860439L 15866149L 15874146L 15799744L 15831079L 15835572L 15844350L 15860442L 15866151L 15874721L 15799745L 15831080L 15837772L 15844354L 15860443L 15866153L 15874722L 15799746L 15831081L 15837774L 15849427L 15860444L 15867659L 15874723L 15800549L 15831082L 15837776L 15849428L 15860454L 15867660L 15874724L 15801685L 15831083L 15837778L 15849429L 15860455L 15867661L 15874725L 15819521L 15831084L 15837780L 15849430L 15860472L 15867662L 15875226L 15819522L 15831085L 15837782L 15849431L 15862036L 15867664L 15875227L 15819524L 15831086L 15839401L 15849432L 15862037L 15867665L 15875573L 15819525L 15831087L 15839402L 15849433L 15862038L 15867666L 15875574L 15819526L 15832438L 15839403L 15849434L 15862039L 15867667L 15876179L 15819527L 15832439L 15839404L 15849435L 15862040L 15867668L 15876180L 15819528L 15832440L 15839405L 15849436L 15862041L 15867669L 15876252L 15819529L 15832441L 15791524L 15804564L 15814869L 15826605L 15845939L 15861329L 15877241L 15791525L 15804565L 15814871L 15826606L 15845941L 15861330L 15880771L 15791528L 15806206L 15814875L 15828091L 15845943L 15867134L 15880773L 15791531L 15806207L 15820199L 15828092L 15845945L 15867135L 15880775L 15795192L 15809765L 15820202L 15828093L 15845947L 15867136L 15880777L 15795194L 15809766L 15820203L 15828094L 15845948L 15867137L 15880779L 15795195L 15809768L 15820205L 15832442L 15845949L 15867138L 15880780L 15795196L 15809769L 15820207L 15832443L 15845951L 15867139L 15880781L 15795197L 15809771L 15820209L 15832444L 15845952L 15867140L 15880782L 15795199L 15809772L 15820210L 15832445L 15845954L 15867141L 15880783L 15795201L 15809773L 15820211L 15832446L 15847790L 15867142L 15880802L 15796589L 15809775L 15820212L 15832447L 15851524L 15867143L 15882334L 15800484L 15809778L 15820213L 15836391L 15851526L 15871415L 15882335L 15800485L 15809779L 15821729L 15836392L 15851527L 15871416L 15882336L 15800486L 15810492L 15821730L 15836393L 15851528L 15871417L 15882337L 15800487L 15810493L 15821731L 15836394L 15851529L 15871418L 15882338L 15800488L 15810494L 15821732L 15836395L 15851530L 15871419L 15882339L 15800489L 15810495L 15821733L 15836396L 15851532L 15871420L 15882340L 15800490L 15810496L 15821734L 15836397L 15851533L 15871421L 15882341L 15800491L 15810497L 15821735L 15836398L 15851534L 15871422L 15882342L 15800492L 15810498L 15821736L 15836399L 15851535L 15871423L 15882343L 15800493L 15810499L 15821737L 15836400L 15855753L 15871424L 15883705L 15801686L 15810500L 15821738L 15837783L 15856692L 15875826L 15883706L 15803963L 15810501L 15822445L 15837784L 15856693L 15875827L 15883707L 15803964L 15814332L 15822449L 15837785L 15856694L 15875828L 15883708L 15803965L 15814334L 15822451L 15837786L 15856695L 15875829L 15883717L 15803966L 15814337L 15822453L 15840278L 15856696L 15875830L 15883720L 15803967L 15814339L 15822455L 15840279L 15856697L 15875831L 15883724L 15803968L 15814340L 15822457L 15840280L 15856698L 15875832L 15883725L 15803969L 15814341L 15822458L 15840281L 15856699L 15875833L 15883728L 15803970L 15814342L 15822460L 15840282L 15856700L 15875834L 15883732L 15803971L 15814343L 15822463L 15840285L 15856701L 15875835L 15886612L 15803972L 15814344L 15822468L 15840288L 15860360L 15877232L 15886620L 15804551L 15814345L 15826597L 15840291L 15861317L 15877233L 15886626L 15804552L 15814849L 15826598L 15840292L 15861318L 15877234L 15886628L 15804553L 15814853L 15826599L 15840293L 15861319L 15877235L 15886633L 15804559L 15814856L 15826600L 15843378L 15861320L 15877236L 15886642L 15804560L 15814859L 15826601L 15843379L 15861321L 15877237L 15886646L 15804561L 15814862L 15826602L 15843380L 15861324L 15877238L 15886650L 15804562L 15814864L 15826603L 15843381L 15861326L 15877239L 15886654L 15804563L 15814867L 15826604L 15843382L 15861327L 15877240L 15886660L 15796590L 15811194L 15816732L 15831852L 15840941L 15874729L 15878249L 15796591L 15811195L 15816733L 15831853L 15840943L 15874730L 15878250L 15796595L 15811196L 15816734L 15831854L 15840945L 15875189L 15878251L 15796596L 15811197L 15816736L 15831855L 15846689L 15875190L 15878252L 15796597L 15811199L 15816737L 15831856L 15846691L 15875191L 15878253L 15796598L 15811200L 15816738L 15831857L 15846693L 15875192L 15878254L 15796599L 15811691L 15816739L 15831862L 15846694L 15875193L 15881371L 15796600L 15811692L 15820991L 15831864L 15846695L 15875194L 15881375L 15801687L 15811693L 15820993L 15831867L 15846697L 15875195L 15881377L 15801688L 15811694L 15820994L 15837108L 15846698L 15875197L 15881382L 15801689L 15811695L 15820996L 15837109L 15846699L 15875198L 15881387L 15801690L 15811696L 15820998L 15837110L 15846700L 15875200L 15881390L 15801691L 15811697L 15821001L 15837111L 15846701L 15876600L 15881394L 15801692L 15811698L 15821003L 15837112L 15862716L 15876601L 15881397L 15801693L 15811699L 15821004L 15837113L 15862717L 15876602L 15881399L 15801694L 15811700L 15821006L 15837114L 15862719L 15876603L 15881401L 15806208L 15815781L 15821008L 15837115L 15862720L 15876604L 15882802L 15806209L 15815782L 15827311L 15837116L 15862721L 15876605L 15882803L 15806210L 15815783L 15827312L 15837117L 15868809L 15876606L 15882804L 15806211L 15815785L 15827313L 15840932L 15868810L 15876607L 15882805L 15806212L 15815786L 15827314L 15840933L 15868812L 15876608L 15882806L 15806213L 15815787L 15827315L 15840934L 15868814L 15876609L 15882807L 15806214L 15815788L 15827316L 15840935L 15868816L 15878245L 15882808L 15806215L 15815790L 15827317L 15840936L 15874726L 15878246L 15882809L 15811191L 15815791L 15827318L 15840937L 15874727L 15878247L 15882810L 15811192L 15816730L 15827319L 15840939L 15874728L 15878248L 15882811L 15811193L 15816731L 15827320L	Class II	Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft.	Biosense Webster, Inc.
Biologics	Red Blood Cells Leukocytes Reduced	W051714101583	Class III	Blood product, for which the additive solution was not added during manufacturing, was distributed.	Rhode Island Blood Center
Biologics	Blood and Blood Products for Reprocessing	W036813023947	Class III	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.	OneBlood, Inc.
Biologics	Plasma Frozen within 24 hours (FP24)	W036813256009	Class II	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.	OneBlood, Inc.
Biologics	Red Blood Cells Leukocytes Reduced	W036813256009	Class II	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.	OneBlood, Inc.
Biologics	Red Blood Cells	W036813023947, 2300334	Class II	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.	OneBlood, Inc.
Biologics	Platelets Pooled Leukocytes Reduced	W036813817523, 2909442	Class II	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.	OneBlood, Inc.
Devices	Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).	Lots: MK761655, MK764022, MK767655, MK526401	Class II	Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may or may not be easily seen.	Gyrus Medical, Inc
Biologics	Terasaki HLA Tissue Typing Trays (HLA Class II Tissue Typing Trays only). Terasaki HLA Tissue Typing Trays are for use in determining HLA cell surface antigens with a complement dependent microlymphocytotoxic technique. BK840023	Catalog ID - DR72; Lot Number - 030; Batch 087	Class III	HLA typing assay, associated with false positive results, was distributed.	One Lambda Inc
Devices	XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional radiation dose distributions within a patient for a given treatment.	Versions 4.1 and higher	Class II	Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.	Elekta, Inc.
Devices	REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.	249649, 102928, 102929, 109312, 128472, 142839, 142840, 142841, 162485, 196050, 196051, 196052, 211382, 211387, 213581, 227387, 231687, 249644, 249647, 269701, 269702, 288346, 298769, 298770, 298772, 306503, 306505, 329328, 338142, 346434, 354575, 360633, 360634, 366429, 366430, 373254, 378641, 378642, 378644, 402462, 403004, 403005, 403007, 403008, 421300, 438246, 438247, 438248, 438249, 452447, 456738, 456740, 466369, 466370, 466371, 058401LA, 137401LA, D2WBG4, D37FW4, D37GP4, DV6LY4, DY5EC4, DY5ED4, E1VHM4, E3SDW4, E6CE94, E82E14, EA8EH4, EF5BS4, EJ6G34, EW6HT4, FJ3D14, FJ3D24, and FJ3DY4	Class II	DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM® Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implant s packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended.	DePuy Orthopaedics, Inc.
Devices	REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.	102325, 102326, 109315, 109316, 120082, 128475, 142843, 142845, 162487, 197812, 197813, 197814, 207924, 222654, 222657, 231689, 231690, 236435, 236442, 261758, 265711, 265714, 265715, 265717, 282997, 285154, 285155, 289096, 302804, 302807, 302808, 317754, 317755, 338154, 338155, 338157, 354580, 360635, 360636, 366432, 378645, 378647, 378650, 400505, 400506, 402456, 414735, 414736, 414737, 430481, 451998, 451999, 452448, 456741, 456742, 456743, 472193, 472194, 472195, 197401RA, D2WBJ4, DY5EF4, E3SD14, E49HN4, EW6HW4, EW6HX4, and FK8CR4	Class II	DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM® Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended.	DePuy Orthopaedics, Inc.
Devices	REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.	E1VHS4, 430482, 338164, 373256, 395802, 409578, 448220, 409582, 238688, 430483, 306508, 329330, 264451, 448222, 216275, 373255, 346439, 409580, 338165, 250929, 360638, D65FJ4, 216277, 395804, EJ7F14, 254740, 302815, FF8DW4, 314821, 464642, 338166, FA4FP4, FA4FT4, 238411LC, 464643, 278448, 409579, 464640, 395803, 088411LA, 308248, FF8DX4, 196411LA, 448227, C1VCE4, 402352, 346437, 366433, 238687, 172188, 329332, 250931, 464641, 216274, 302813, 295384, 264453, 337411LA, 120084, 236445, 289043, 329331, 308247, and 395806	Class II	DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM® Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended.	DePuy Orthopaedics, Inc.
Devices	REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.	102932, 102933, 102934, 120086, 142854, 156155, 156156, 156157, 162493, 172189, 181460, 181462, 193663, 231692, 231695, 236448, 241369, 241371, 246794, 261763, 269712, 278450, 278451, 278452, 282999, 283000, 283001, 291033, 291034, 302817, 306511, 306512, 306513, 317757, 317758, 329334, 338167, 338168, 346440, 360639, 360640, 360641, 366434, 366435, 366436, 378652, 392023, 400513, 400514, 406837, 409583, 412683, 414752, 430490, 430491, 430492, 448537, 456744, 456745, 456747, 456748, 464644, 464646, 464647, 266411RA, 467411RB, D1TAN4, E1VHX4, E4EGB4, E73H74, E82E74, E82E84, E82E94, EN7JC4, EW6H24, FK8GP4, and FL1VH4.	Class II	DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended.	DePuy Orthopaedics, Inc.
Devices	REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.	Both left and Right 102935, 110571, 114271, 114274, 114277, 128477, 132946, 142857, 156158, 162498, 162499, 162500, 172191, 172194, 193664, 193668, 217297, 224704, 229189, 229192, 229195, 229196, 236454, 236463, 236466, 241379, 249713, 249714, 249715, 254742, 254743, 260549, 260552, 269715, 269717, 278454, 278456, 283005, 283006, 283007, 291037, 291038, 291039, 295391, 302819, 306516, 306517, 314828, 314831, 314832, 317759, 317761, 317765, 317769, 317770, 317772, 329335, 338170, 338171, 338173, 338176, 346442, 354609, 354614, 360644, 360645, 360646, 360647, 366437, 366439, 366440, 373257, 373258, 378654, 378655, 378657, 378660, 385029, 385031, 385033, 385034, 392028, 392029, 392032, 400543, 400544, 402441, 403009, 403012, 409586, 414761, 414762, 414763, 414764, 414765, 414766, 414767, 430493, 430494, 430495, 430496, 430498, 438592, 438593, 438594, 438595, 438596, 438597, 438598, 438599, 448539, 452452, 453170, 453171, 453172, 456749, 456751, 456752, 456753, 456754, 470494, 470496, 470503, 470504, D51B54, D51B64, D51B84, D51B94, DN5ET4, DY5EP4, E4EGG4, E5WCF4, E6CFK4, FD6G14, FE2DP4, FL8AM4	Class II	DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended.	DePuy Orthopaedics, Inc.
Devices	REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.	Both Right and Left 102935, 110571, 114271, 114274, 114277, 128477, 132946, 142857, 156158, 162498, 162499, 162500, 172191, 172194, 193664, 193668, 217297, 224704, 229189, 229192, 229195, 229196, 236454, 236463, 236466, 241379, 249713, 249714, 249715, 254742, 254743, 260549, 260552, 269715, 269717, 278454, 278456, 283005, 283006, 283007, 291037, 291038, 291039, 295391, 302819, 306516, 306517, 314828, 314831, 314832, 317759, 317761, 317765, 317769, 317770, 317772, 329335, 338170, 338171, 338173, 338176, 346442, 354609, 354614, 360644, 360645, 360646, 360647, 366437, 366439, 366440, 373257, 373258, 378654, 378655, 378657, 378660, 385029, 385031, 385033, 385034, 392028, 392029, 392032, 400543, 400544, 402441, 403009, 403012, 409586, 414761, 414762, 414763, 414764, 414765, 414766, 414767, 430493, 430494, 430495, 430496, 430498, 438592, 438593, 438594, 438595, 438596, 438597, 438598, 438599, 448539, 452452, 453170, 453171, 453172, 456749, 456751, 456752, 456753, 456754, 470494, 470496, 470503, 470504, D51B54, D51B64, D51B84, D51B94, DN5ET4, DY5EP4, E4EGG4, E5WCF4, E6CFK4, FD6G14, FE2DP4, FL8AM4	Class II	DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended.	DePuy Orthopaedics, Inc.
Devices	Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek® polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.	Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018	Class II	Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected.	Megadyne Medical Products, Inc.
Biologics	Cornea	111215OD; 111215OS	Class II	Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.	Upstate New York Transplant Services
Devices	Boston Scientific, RunWay" Guide Catheter, UPN H749389696640, Catalog Number 38969-664.	2013040058	Class II	Boston Scientific is initiating this Recall Removal of one lot (2013040058) of the RunWay" Guide Catheter. Boston Scientific has become aware that the sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. To date, Boston Scientific has received one complaint for this issue. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.	Boston Scientific Corporation
Biologics	Cornea	01272013060OS; 01272013060OD	Class II	Human corneas, recovered from a donor who was not properly evaluated for hemodilution, were distributed.	Mid-America Transplant Services
Drugs	Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle Biologics, Inc. Bannockburn, IL 60015. NDC:76128-155-75	Lot Number: 0M396; Expiry: Nov 2014	Class III	Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.	Pinnacle Biologics Inc
Biologics	Blood and Blood Products for Reprocessing	W036808110290;	Class III	Blood products, collected from a donor whose suitability to donate was not fully evaluated, was distributed.	OneBlood, Inc.
Biologics	Red Blood Cells Leukocytes Reduced	W036808110290;	Class II	Blood products, collected from a donor whose suitability to donate was not fully evaluated, was distributed.	OneBlood, Inc.